Jazz：zanidatamab 1L HER2+ GEA sBLA 获优先审评；PDUFA 日期为 2026 年 8 月 25 日

FDA 已受理 zanidatamab sBLA 并授予优先审评资格。FDA 设定的 PDUFA 目标行动日期为 2026 年 8 月 25 日，为一线 HER2+ 胃食管腺癌的潜在获批和上市确立了明确的监管时间表。

关键事实

申报时间: 2026年5月5日 20:06
事件: PDUFA 日期确定
方向: 积极
公司: JAZZJazz Pharmaceuticals
资产: zanidatamab
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年8月25日 · 已批准

来源摘录

EX-99.1 2 a1q26financialpr.htm EX-99.1 Document Exhibit 99.1 Jazz Pharmaceuticals Announces First Quarter 2026 Financial Results – Strong commercial execution across franchises with total revenues of $1.1 billion (+19% YoY) – – Zanidatamab HER2+ 1L GEA sBLA granted Priority Review; PDUFA date of August 25, 2026 – – Xywav ® revenues grew 18% YoY with 425 net patient adds – – Epidiolex ® revenues grew 15% YoY– – Company reaffirms 2026 revenue and expense guidance – DUBLIN, May 5, 2026 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2026 (1Q26). “Our first-quarter results reflect disciplined execution across the business, delivering 19% year-over-year growth alongside key pipeline advancements and positioning the company for an o

SEC 8-K